ISRCTN75684296已完成未知
A multicentre, randomized, double-blind, placebo-controlled, parallel-design trial of the efficacy and safety of subcutaneous tetrodotoxin (Tectin) for moderate to severe inadequately controlled cancer-related pain
Wex Pharmaceuticals Inc (Canada)0 个研究点目标入组 82 人开始时间: 2005年11月7日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 82
研究概览
简要总结
2008 results in https://pubmed.ncbi.nlm.nih.gov/18243639/ (added 12/01/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Male or female 18 years of age and over
- •2. In-patients or out-patients with a diagnosis of cancer
- •3. Stable but inadequately controlled pain with current therapy for at least two weeks
- •4. Patients must be experiencing somatic, visceral and/or neuropathic pain related to cancer
- •5. Pain intensity, assessed by Question #3 of the Brief Pain Inventory (BPI short form) meets the definition of 'moderate' (score of 4-5) or 'severe' (score of 6-10) pain
- •6. Life expectancy of >3 months
- •7. Ability to communicate well with the Investigator and to comply with the requirements of the entire study
- •8. Willingness to give written informed consent (prior to any study-related procedures being performed) and to be able to adhere to the study restrictions, appointments, and examination schedule
排除标准
- •1. Planned initiation of chemotherapy, radiotherapy, or bisphosphonates within 30 days prior to randomization
- •2. Use of anaesthetics
- •3. Use of lidocaine and other types of antiarrhythmic drugs
- •4. Use of scopolamine and acetylcholinesterase-inhibiting drugs such as physostigmine
- •5. History of CO2 retention, or SaO2 <90% either on room air or O2 of not greater than 2-4 l/min by nasal cannula
- •6. Second or third degree heart block or prolonged QTc interval (corrected for rate) on screening electrocardiogram(ECG) (confirmed >450 msec on repeated occasion) or any other active cardiac arrhythmia or abnormality that could constitute a clinical risk
- •7. Coagulation or bleeding defects if in the opinion of the Investigator this represents a risk to the subject considering the subcutaneous (sc) route of administration
- •8. Known hypersensitivity to puffer fish, tetrodotoxin and/or its derivatives
- •9. Received an investigational agent within 30 days prior to screening or who is scheduled to receive an investigational drug other than tetrodotoxin during the course of the study
- •10. Previous use of tetrodotoxin
- •11. Females who are lactating or at risk of pregnancy (i.e. sexually active with fertile males and not using an adequate form of birth control)
- •12. Females with a positive serum pregnancy test at screening or positive urine pregnancy test on admission to study site
- •13. Any other condition that, in the opinion of the investigators, is likely to interfere with the successful collection of the measures required for the study or poses a risk to the patient
研究者
相似试验
已完成
2 期
Repurposing anti-TNF for treating Dupuytren’s diseaseDupuytren's disease of the handSkin and Connective Tissue DiseasesDupuytren's diseaseISRCTN27786905niversity of Oxford181
已完成
不适用
Evaluating the effects of early administration of fibrinogen concentrate in adults with major traumatic haemorrhage.Topic: Injuries and Emergencies, HaematologySubtopic: Injuries and Emergencies (All Subtopics), Haematology (All Subtopics)Disease: Injuries and Emergencies, Non-malignant HaematologyInjury, Occupational Diseases, PoisoningISRCTN67540073HS Blood and Transplant (NHSBT)48
已完成
3 期
Study of mirtazapine for agitation in dementiaISRCTN17411897niversity of Sussex247
已完成
不适用
aminar airflow in severe asthma for exacerbation reductioAsthmaISRCTN46346208Queen Alexandra Hospital (UK)240
已完成
不适用
Managing Avascular Necrosis Treatments: an Investigational Study (MANTIS)Avascular necrosis of the hipMusculoskeletal DiseasesOsteonecrosisISRCTN14015902niversity of Oxford21